NCT04411901

Brief Summary

Vitamin D3 therapy was effective in decreasing the frequency of pulmonary exacerbations and preserving lung functions , thereby improving the disease severity even more in non CF than CF bronchiectasis patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

May 22, 2020

Last Update Submit

May 28, 2020

Conditions

Cystic Fibrosis and Non CF Bronchiectasis

Outcome Measures

Primary Outcomes (2)

  • reach sufficient vitamin D level

    vitamin D more than 30 ng/dl

    6 months

  • decrease disease severity

    decrease excerbations and increase lung function

    6 months

Study Arms (1)

vitamin D 3

EXPERIMENTAL

oral vitamin D3 drops and tablets

Drug: Cholecalciferol (vitaminD3)

Interventions

Cholecalciferol (vitaminD3)DRUG

Theraputic vitamin D3 for CF and non CF bronchiectasis children

vitamin D 3

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ages less than 18 years .
  • Patients with documented diagnosis of CF (by the presence of a twice positive sweat chloride test and or paired CFTR DNA genetic mutations).
  • Patients with non CF bronchiectasis diagnosed clinically and radiologically ( sweat chloride test negative) with a high resolution CT-confirmed diagnosis and clinical history consistent with bronchiectasis .
  • Vitamin D deficient or insufficient CF and non CF bronchiectasis patients

You may not qualify if:

  • sufficient Vitamin D level .
  • chronic lung diseases other than CF and non CF bronchiectasis , liver or renal diseases.
  • reported taking vitamin-D supplements or steroid therapy in the last 6 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children hospital

Cairo, Abbasia, 02, Egypt

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 22, 2020

First Posted

June 2, 2020

Study Start

March 1, 2018

Primary Completion

September 6, 2018

Study Completion

March 20, 2019

Last Updated

June 2, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)